Method for drug formulation and a pharmaceutical composition

Patent 5476667 Issued on December 19, 1995. Estimated Expiration Date:

April 16, 2013. Estimated Expiration Date is calculated based on simple USPTO term provisions. It does not account for terminal disclaimers, term adjustments, failure to pay maintenance fees, or other factors which might affect the term of a patent.

Abstract Claims Description Full Text

Patent References

Delayed release pharmaceutical preparations
Patent #: 4013784
Issued on: 03/22/1977
Inventor: Speiser

Method of providing pellets with a water insoluble coating using a melt
Patent #: 4129666
Issued on: 12/12/1978
Inventor: Wizerkaniuk

Process for preparing oral sustained release granules
Patent #: 4132753
Issued on: 01/02/1979
Inventor: Blichare , et al.

Method for preparing a pharmaceutical controlled release composition
Patent #: 4572833
Issued on: 02/25/1986
Inventor: Pedersen , et al.

Process for the coating of granules
Patent #: 4935246
Issued on: 06/19/1990
Inventor: Ahrens

Process for preparing etofibrate or similar compounds containing sustained release microgranules and products thus obtained
Patent #: 4957746
Issued on: 09/18/1990
Inventor: Valducci

Oral composition containing particles comprising an active substance Patent #: 5147655
Issued on: 09/15/1992
Inventor: Ibsen

Inventors

Assignee

Kabi Pharmacia AB

Application

No. 039175 filed on 04/16/1993

US Classes:

424/489, Particulate form (e.g., powders, granules, beads, microcapsules, and pellets)424/467, Printed, embossed, grooved, or perforated424/490, Coated (e.g., microcapsules)424/497Containing solid synthetic polymers

Examiners

Primary: Page, Thurman K.
Assistant: Benston, William E. Jr.

Attorney, Agent or Firm

Birch, Stewart, Kolasch & Birch

International Class

A61K 009/14

Foreign Application Priority Data

1990-10-16 SE

Abstract

A melt granulating method for the production of pellets (spheres) which contain a therapeutically active substance of high-dosage type. The method is characterized by: (i) mechanically working a mixture which contains (a) the active substance in cohesive form and (b) a binder (melting point 40° C.-100° C.) while supplying sufficient energy for the binder to melt and to form spherical overwetted pellets; (ii) adding further cohesive substance, while maintaining the mechanical working; (iii) interrupting the mechanical working and supply of energy and cohesive substance when the desired mean particle size of dry pellets (spheres) has been achieved; and (iv) removing the smallest and largest particles and dividing the remaining pellets into dosage batches. A novel pharmaceutical composition containing a dosage of 300-500 mg of pellets is obtainable from this process.

Other References

Drug Development And Industrial Pharmacy vol. 16, No. 8, 1990 T. Schaefer et al: "Melt granulation in a laboratory scale high shear mexer", pp. 1249-127